Provision for Manufacturing and Servicing Provision in a form consistent with the FDA QSR.
By clarifying how to the Manufacturing and Servicing, it is possible to standardize within the company.
Standardization will facilitate responses in the event of FDA inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K7 Manufacturing and Servicing Provision

Table of Contents

Provision

1. purpose
2. scope of application
3. Definition of Terms
4. general provision
5. Infrastructure
5.1 Qualification of equipment
5.2 Maintenance activities
6. working environment control and hygiene control in manufacturing plants
6.1 Working environment control
6.2 Personnel
6.3 Contamination control
7. control of manufacturing and service provision
7.1 Product cleanliness control
7.2 Substances used in manufacturing
7.3 Automated processes
7.4 Control of customer property
8. document control
8.1 Product standard documentation/device material register (DMR)
8.2 QC process chart
8.3 Manufacturing Instructions and Records
8.4 Receiving inspection record
8.5 Manufacturing history record (DHR)
8.6 Shipping Decision Form
9. ensuring proper manufacturing control and quality control
9.1 Arrangements with manufacturers, etc.
9.2 Control of shipment to the market
10. initial flow control
11. control of deviations
12. manufacturing and process changes
13. equipment for inspection, measurement and testing
13.1 Control of inspection, measurement and test equipment
13.2 Calibration
14. criteria for corrective and preventive action requests
15. reference
16. supplementary provision